Invokana amputations prompt FDA’s severe Boxed Warning

In a Drug & Safety Communication released May 2017, and updated July 2017, The FDA confirmed the risk of leg and foot amputations happened nearly twice as high in those taking Invokana, a diabetes drugs known as a SGLT2 inhibitor. This confirmation comes after the conclusion of a study known as CANVAS, or the Canagliflozin Cardiovascular Assessment Study; originally conducted to test the affects of Invokana on the heart. However, the results of the study showed that the most severe side effects of Invokana may result in areas a lot further from the heart.

According to the CANVAS study, out of 1,000 patients studied 5.9 of them had the higher risk of amputation as a result of taking Invokana. This stood in contrast to the 1,000 patients taking a placebo. Only 2.8 of patients taking the placebo had a high a risk of amputation.

A second study called the CANVAS-R, a study of the effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus, was also conducted and confirmed the higher risk of amputation due to Invokana with its results as well. As a result the FDA has required the diabetes drug to carry it’s most severe label, known as the black box label, or Boxed Warning.

If you or a loved one has experienced a life changing side effect like an amputation, contact us today for a free case evaluation on your Invokana amputation lawsuit.

Understanding the FDA’s Black Box Warning

The black box warning is the FDA’s most severe warning because it indicates the risk for severe or life-threatening prescription drug side effects. They are designed to bring awareness to the doctors prescribing the drug, and more importantly the patients who will be consuming the drug.

Invokana’s recent requirement of the black box warning, prompted by the increased risk of amputation is not it’s first labeling of this kind, but it second. Invokana is already required to carry a boxed warning due to potential side effects of one of it’s ingredients, Metformin.

In addition, in the case of Invokana, many patients were prescribed the diabetes medication before this new severe labeling was required by the FDA in May of 2017; putting many of those consumers at risk for amputation and another FDA identified side of Invokana, Ketoacidosis.

The FDA has also released a bevy of Drug and Safety communications regarding Invokana, and its partner drug Invokamet, since early 2015. Pinning the drug for side effects like bone fracture, kindey infections, and diabetic ketoacidosis, or DKA in addition to the amputation risk.

In regards to those taking Invokana who may be at risk for amputation, the FDA notes that patients who have developed sores, ulcers, tenderness or infections in their legs and feet should contact their healthcare professionals at once.

15 Amputations Recorded Due to Invokana

During the time the clinical trials were conducted amputations actually occured within the pool of patients taking Invokana. The authors of the study reported to the New England Journal of Medicine.

“The increased rate of amputation is a new finding for which the mechanism is unknown.”

Over the course of 5 years in the 1,000 patients studied there were a total of 15 amputations conducted. With 10 of those amputations involving a patients toe or foot and 5 amputations that were above the ankle, including an above the knee leg amputation.

Invokana Amputation Lawsuit

If you have experienced suffering from taking your diabetes medication it is important to understand your rights. Serious illness like amputations, bone fractures, kidney failure, and diabetic ketoacidosis can disrupt your like and pose life threatening consequences.

Greg Jones Law has sued many major drug manufacturers for failing to warn of the dangers of their drugs. We have the means and the experience to represent clients throughout the United States in pharmaceutical litigation. Our pharmaceutical litigation attorney’s are ready to help you with an Invokana amputation lawsuit.

To find out if you have a case against the makers of the medications Invokana or Invokamet contact us today for a free case evaluation. Call 855-566-3752 or contact us online.

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